Kornimate/medical-research-clean huggingface dataset:
everolimus versus placebo in head and neck cancer

Conditions: Head and Neck Cancer

Summary: primary: two-year progression-free (tumor does not grow or spread) survival in subjects treated with everolimus versus placebo after definitive local therapy.


Eligibility criteria:
inclusion criteria: * diagnosis of squamous cell carcinoma of the head and neck (stage iva or ivb). no evidence (absence)of disease by scan. * 18 years or older. * performance status 70% or better. * adequate marrow, renal and liver function (will be tested by labs). _ able give consent. exclusion criteria: * currently receiving anti-cancer treatment. * major surgery or traumatic injury within 4 weeks. * radiotherapy related toxicities. * lip, nasopharynx, nasal cavity, paranasal sinus, salivary gland, skin, or thyroid primary tumors * receiving other investigational drugs. * receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. * receive immunization with attenuated live vaccines (seasonal flu shot)1 week before starting this . * show evidence of disease (cancer). * uncontrolled medical conditions such as: unstable angina, congestive heart failure, diabetes, severely impaired lung function. * liver disease such as cirrhosis, severe hepatic impairment, hepatitis b or c. * active, uncontrolled severe infections * other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin. * known history of hiv positivity. * impaired gastrointestinal function that may alter absorption of everolimus such as ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection. * patients with an active, bleeding diathesis. * female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. ) * male patient whose sexual partner(s) are women of child bearing potential who are not willing to use adequate. contraception, during the study and for 8 weeks after the end of treatment * patients who have received prior treatment with an mtor inhibitor (sirolimus, temsirolimus, everolimus). * patients with a known hypersensitivity to everolimus or other rapamycin analogues (sirolimus, temsirolimus) or to its excipients. * history of noncompliance to medical regimens. * patients unwilling to or unable to comply with the protocol.

Keywords: squamous cell cancer
adjuvant fec versus ep in breast cancer (mig5)

Conditions: Breast Cancer; Chemotherapy, Adjuvant

Summary: in this multicenter, randomized phase iii trial, node positive early breast cancer patients are randomly assigned to receive either 6 cycles of fec (5-fluorouracil 600 mg/m2, epirubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, on day 1, every three weeks) or 4 cycles of ep (epirubicin 90 mg/m2 and paclitaxel 175 mg/m2, on day 1, every three weeks). the primary study endpoint is overall survival (os). secondary endpoints include toxicity and event free survival (efs).

at the time the gruppo oncologico nord-ovest- mammella intergruppo trial 5 (gono-mig5) was designed in 1996, paclitaxel was known to have efficacy in patients with advanced breast cancer, but its role was still to be established in the adjuvant setting. therefore the gono-mig5 trial was designed to compare a standard anthracycline-containing chemotherapy regimen, i.e. 5fluorouracil, epirubicin, ciclophosphamide (fec), given for 6 cycles to a new regimen containing both epirubicin and paclitaxel (ep), given concurrently, for 4 cycles. this latter regimen was chosen on the basis of the results obtained in metastatic breast cancer patients, where the combination of doxorubicin and paclitaxel was associated with more than 90% of objective response . only four cycles of the new regimen were planned since the expected toxicity, particularly the cardiotoxicity, was high, and a short treatment duration was hoped to be the best strategy to obtain a favourable balance between the toxicity and the expected high efficacy.

Eligibility criteria:
inclusion criteria: * women with histologically confirmed breast cancer who had undergone radical mastectomy or breast-conserving surgery in addition to full ipsilateral axillary lymph node dissection * lymph node-positive disease with less than 10 involved axillary lymph nodes * surgery performed not more than 5 weeks before randomization * ecog performance status 0 * absolute neutrophil count ≥ 2,000/mm³ * wbc ≥ 3,000/mm³ * platelet count ≥ 100,000/mm³ * bilirubin ≤ 1.5 times upper limit of normal (uln) * ast and alt ≤ 1.5 times uln * postoperative regional radiotherapy limited to the remaining breast admitted for patients who received breast-conserving surgery * written informed consent exclusion criteria: * prior or concurrent ipsilateral or contralateral invasive breast carcinoma within the last 10 years * metastatic disease, including metastasis in the ipsilateral supraclavicular lymph nodes * prior chemotherapy or prior cytotoxic regimens or prior hormonal therapy * pregnant or nursing * other serious medical illness requiring medication, uncontrolled infections * other malignancy except adequately treated, cone-biopsied in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin * recent myocardial infarction, congestive heart failure, or serious arrhythmia

Keywords: early breast cancer adjuvant chemotherapy fec paclitaxel
add on lacosamide versus high dose monotherapy

Conditions: Epilepsy

Summary: this is a study to determine whether a combination of low dose lacosamide and levetiracetam is more effective than high dose levetiracetam in patients who have failed low dose levetiracetam.


Eligibility criteria:
inclusion criteria: 1. adults age 18 or older 2. determined to have had at least two partial seizures by an epilepsy specialist, or to have had a single partial seizure with clinical and/or laboratory evidence of a high seizure recurrence risk 3. monotherapy on levetiracetam less than or equal to 1500 mg/day for at least two weeks 4. breakthrough seizure while on stable dose (\>5 days) of levetiracetam monotherapy regimen, not due to provocative factors (e.g. hypoglycemia, head trauma, missed medications) exclusion criteria: 1. clinical suspicion of nonepileptic psychogenic seizures or idiopathic generalized epilepsy 2. pregnant, child-bearing age not using contraception, or breast feeding 3. medical contraindication to adding lacosamide 4. history of antiepileptic drug (aed) polytherapy 5. presence of a vagus nerve stimulator 6. creatinine clearance of less than 50 ml/min 7. blood pressure instability: pulse \ 100, systolic blood pressure (sbp) \ 180, clinically significant electrocardiogram (ekg) abnormality 8. history of significant drug rash or anaphylactic reaction with antiepileptic drug 9. patients with progressive lesions (e.g. brain tumors)

Keywords: epilepsy antiepileptic drug polytherapy
follow-up study of the rai-treated hyperthyroid patients

Conditions: Hyperthyroidism; Cardiovascular Diseases; Atrial Fibrillation

Summary: previous studies of hyperthyroid patients suggest that they remain at increased risk of cardiovascular morbidity after restoring euthyroidism. the study objective is to compare the rate and causes of hospitalization of hyperthyroid patients treated with radioactive iodine (rai) with those of an age- and gender-matched reference population in a long-term follow-up study.

a population-based cohort study was conducted among 2611 hyperthyroid patients treated with rai between 1969 and 2002 in tampere university hospital, and among 2611 reference subjects. a reference group was randomly selected, with an age- and gender-matched control subject identified for each patient from the population register centre. the control subject had to be alive at the time when the patient received the first rai treatment. the causes of hospitalization as well as the diagnosis and date of hospital admission were obtained from the nationwide hospital discharge register (hilmo) maintained by the research and development centre for welfare and health (stakes) using a computerized record linkage, with the personal identification number as the key. the hilmo database covers all dates and causes of hospitalization (hospital admission requiring an overnight stay) of the finnish citizens since january 1969. new events were analyzed as the main outcome, including only the first hospitalization due to a given indication. the special focus was on the cardiovascular morbidity.

Eligibility criteria:
inclusion criteria: * patients: radioiodine treatment for hyperthyroidism given in the tampere university hospital between january 1969 and june 2002 * controls: age- and gender-matched control subject identified for each patient from the population register centre. the control subject had to be alive at the time when the patient received the first rai treatment

Keywords: radioiodine hyperthyroidism morbidity cardiovascular diseases
arthroscopic versus open excision of dorsal wrist ganglion

Conditions: Hand Ganglion

Summary: compare recurrence rates after open and arthroscopic excision of dorsal wrist ganglion

dorsal ganglions (dgs) are one of the most frequent problems of the wrist. they represent benign soft tissue tumors that frequently remain asymptomatic. suggested causes include trauma to the scapholunate joint, degeneration of tissue lining a tendon or sheath near the joint, and synovial herniation in most cases, diagnosis is based on history and physical examination. patients seek treatment when these ganglions become associated with pain, weakness, interference with activities, and an increase in size other than observation, nonoperative treatment such as closed rupture, ganglion puncture, and needle aspiration is associated with relatively higher rates of recurrenceas high as 78%. surgical treatment with either open or arthroscopic excision is therefore offered with a lower risk of recurrence. whereas open excision has historically been the traditional method of surgical treatment, arthroscopic excision has been suggested as a potentially more favorable alternative. proponents of wrist arthroscopy proclaim an advantage of decreased postoperative pain, earlier return of functions, and a smaller incision. moreover, preliminary and subsequent studies have described arthroscopic dg excision as having equal or lower rates of recurrence. however, the results of arthroscopic versus open procedures have never been directly compared.

Eligibility criteria:
inclusion criteria: * patients with a primary, simple dg with no underlying pathology of the wrist who sought surgical treatment. exclusion criteria: * 1. prior ganglion treatment (rupture, puncture, aspiration, or excision) 2. previous surgery 3. history of a fracture 4. ligamentous tear or wrist instability 5. patients with major medical problems 6. unacceptable anesthetic risks, 7. acquired or congenital abnormalities of wrist function or motion
intensive executive function training

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the investigators intent to recruit 80 attention deficit hyperactivity disorder families. the attention deficit hyperactivity disorder families had received executive function training one year before.they will be randomized to intervention group and control group using a block randomization design. the intervention group will participate in intensive executive function training immediately,while the control group will receive executive training after 3 months.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of child attention deficit hyperactivity disorder * full-scale intelligence quotient (fsiq) ≥70 * stable on medication for attention deficit hyperactivity disorder children at least 3 months * participation in the early implementation of functional training one year before exclusion criteria: * individuals with major neurological disorders * a diagnosis of schizophrenia, epilepsy, mental retardation or other brain disorders
study of carboplatin and vinorelbine in malignant pleural mesothelioma

Conditions: Malignant Pleural Mesothelioma

Summary: the purpose is to evaluate the activity and feasibility of a two drug regimen which is partly orally and partly intravenous in advanced pleural mesothelioma.

chemotherapy with carboplatin i.v. day one in each cycle vinorelbine i.v. day one, and orally day 8 in each cycle, repeat new cycle every 3 weeks. total of 6 cycles. endpoint is response rate, secondary endpoints survival and toxicity.

Eligibility criteria:
inclusion criteria: * histologically verified malignant pleural mesothelioma * age above 18 years * performance status 0-2 exclusion criteria: * no previous chemotherapy * normal renal, liver and bone marrow function

Keywords: malignant pleural mesothelioma chemotherapy
prediction of esophageal and lung toxicities after radiation (chemo) therapy

Conditions: Lung Cancer

Summary: (chemo)-radiotherapy is the gold standard therapeutic treatment for patients with locally advanced lung cancer non accessible or ineligible for surgery. while some progress occurred regarding progression free survival and overall survival thanks to recent advances (i.e., durvalumab), prediction of pulmonary and esophageal toxicity, remains insufficiently accurate. current dose-volume histograms (dvh) do not account for spatial dose distribution and strict application of current dose constraints does not prevent toxicity events in some of the treated patients. the goal of this work was to investigate the added predictive value of the radiomics approach applied to dose maps regarding acute and late toxicity in both lungs and the esophagus.


Eligibility criteria:
inclusion criteria: * patients treated by (chemo)-radiotherapy for a primary lung cancer by radiotherapy exclusion criteria: * incomplete treatment
individualized functional imaging-guided repetitive transcranial magnetic stimulation (rtms) for treating postural gait disorders in patients with amyotrophic lateral sclerosis (als): a randomized, crossover, controlled, double-blind clinical study

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Summary: this study is a randomized, crossover, controlled, double-blind clinical trial. patients (n=45) were randomly divided into group a and group b. patients in group a will receive 2 weeks (10800 hz daily, 5 days×2) of transcranial magnetic stimulation（tms） treatment, while patients in group b will receive sham stimulation with the same frequency. after a 4-week washout period, the two groups cross over. patients in group a will receive sham stimulation, and patients in group b will receive tms treatment for 2 weeks (10800 hz daily, 5 days×2). clinical functional scales, imaging evaluations, and gait analysis will be conducted at baseline, after 2 weeks of treatment, before crossover treatment, and after 2 weeks of crossover treatment. the therapist, patients, and assessors will be all blinded throughout the study.


Eligibility criteria:
inclusion criteria: 1. aged 18-80 years; 2. diagnosis of motor neuron disease at probable level or above based on estorial criteria;12 3. meet umnd als diagnosis criteria: at least three segments of upper motor neuron damage localized to 1-2 muscles, or emg indicating loss of innervation in 1-2 muscles;13 4. presence of lower limb dysfunction: berg balance scale score below 40; 5. capable of standing independently for more than 30 seconds and able to walk or walk with assistance; 6. stable medication dosage for at least one month; 7. fvc \> 60%; 8. signed informed consent. exclusion criteria: 1. history of substance abuse within the past 6 months; 2. history of epilepsy or first-degree relative with epilepsy; 3. patients with severe systemic diseases in the heart, lungs, liver, or kidneys that cannot be controlled with routine medications, based on laboratory results; 4. patients with severe depression or anxiety (hamd-17 score ≥18; hama score ≥21) or diagnosed with other mental illnesses; 5. patients with a life expectancy of less than one year due to reasons other than neurodegenerative diseases; 6. pregnant women or those planning to become pregnant; 7. individuals with a pacemaker, cochlear implant, or other metallic foreign bodies and any implanted electronic equipment, or those with contraindications for mri scanning or tms treatment, such as claustrophobia; 8. patients who have received tms, transcranial electrical stimulation, transcranial focused ultrasound, or other neuromodulation treatments within three months prior to enrollment; 9. other abnormal examination results deemed unsuitable for participation by the research investigator; 10. inability to cooperate for follow-ups due to geographical or other reasons; 11. participation in other clinical research trials.

Keywords: individualized cortical mapping technology, repetitive transcranial magnetic stimulation, amyotrophic lateral sclerosis, balance and gait disorders.
effect of tunnel placements on clinical and mri findings two years after acl reconstruction with db technique

Conditions: Anterior Cruciate Ligament Rupture

Summary: purpose: to find out whether the clinical and mri findings two years after anterior cruciate ligament (acl) reconstruction were associated with each other so that mri-based graft invisibility in the anteromedial (am) graft would have an impact on anteroposterior stability of the knee, and mri-based posterolateral (pl) graft invisibility on rotational stability of the knee. methods: 75 patients. one experienced orthopaedic surgeon performed all double-bundle (db) acl reconstructions. two independent examiners made the clinical examinations at the two-year follow-up: clinical examination of the knee, kt-1000, international knee documentation committee (ikdc) and lysholm knee evaluation scores and ikdc functional score. the mri evaluations were made by two musculoskeletal radiologists separately and the means of these measurements were used.


Eligibility criteria:
inclusion criteria: * primary acl reconstruction, closed growth plates exclusion criteria: * ligament injury to the opposite knee

Keywords: anterior cruciate ligament reconstruction double-bundle mri graft location
influence of chemotherapy on gamma-delta t cells in patients with epithelial ovarian cancer

Conditions: Ovarian Cancer

Summary: in patients with an ovarian cancer, the treatment is currently based on surgery and chemotherapy. the impact of chemotherapy on the expansion and functional abilities of vgamma9vdelta2 t cells has never been evaluated. the long term goal is to give a rational to combine conventional treatment of ovarian cancer with immunotherapy based on vgamma9vdelta2 t cells.

ovarian cancer is associated with a high mortality rate. treatment of ovarian cancer is currently based on surgery and chemotherapy. the first surgery is a radical surgical procedure aiming to achieve no residual disease. patients who could not benefit from the first surgery may be offered neoadjuvant chemotherapy with a new surgical procedure after 3 or 6 chemotherapy cycles. chemotherapy is currently based on taxol and carboplatin. immunotherapy based on vgamma9vdelta2 t cells could provide a promising therapeutic strategy, however, the impact of chemotherapy on the expansion and functional abilities of vgamma9vdelta2 t cells has never been evaluated. we want to study the effect of chemotherapy of ovarian cancer on vgamma9vdelta2 t cells rates in the peripheral blood of patients with ovarian cancer. functional abilities of the vgamma9vdelta2 t cells will be studied: expansion after chemotherapy and their cytotoxic abilities in an autologous context before or after chemotherapy. the long term goal is to give a rational to combine conventional treatment of ovarian cancer with non-conventional treatment such as immunotherapy based on vgamma9vdelta2 t cells.

Eligibility criteria:
inclusion criteria: * patients with proven epithelial ovarian cancer * patients receiving carboplatin and / or taxol chemotherapy. exclusion criteria: * minor patient * protected adult * lack of invasion to the final histological checking * absence of chemotherapy in the therapeutic plan of treatment

Keywords: ovarian cancer patient with ovarian cancer
changes in liver function after stereotactic body radiation therapy measured by pet/ct

Conditions: Hepatocellular Carcinoma; Cholangiocarcinoma; Metastases; Stereotactic Body Radiotherapy

Summary: patients treated with stereotactic radiotherapy for liver tumors undergo pet/ct using the galactose analogue 18-f-deoxy-galactose (fdgal) before and after radiotherapy. this technique provides volumetric mapping of liver function and it allows quantisation of liver function. the method may be used for selection of patients for stereotactic radiotherapy of liver tumors, for determination of radiation induced liver dysfunction and may be included into the treatment planning process of stereotactic radiotherapy.


Eligibility criteria:
inclusion criteria: * liver tumor * referred for stereotactic radiation therapy * age \> 18 years exclusion criteria: * impaired kidney function * pregnancy

Keywords: liver function galactose 18-f-deoxy-galactose pet/ct stereotactic body radiation therapy sbrt
trial to study the adjuvant benefits of quercetin phytosome in patients with covid-19

Conditions: COVID-19

Summary: the purpose of this study is to investigate if quercetin phytosome is beneficial for the treatment of covid-19.

this is a randomized, open-labelled and controlled study aimed to investigate the adjuvant benefits of quercetin phytosome in community-based subjects with confirmed sars-cov-2 infection (by rt-pcr). the study has two arms. in one arm the subjects will receive standard covid-19 care as per the hospital/physician guidelines, whereas in the other arm the subjects will receive standard covid-19 care + quercetin phytosome. the treatment will continue for 30 days. it is proposed that quercetin phytosome will contribute to boosting the natural immunity of the subjects and will help in preventing the covid-19 disease progression i.e preventing the need of hospitalisation.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years of either gender * confirmed sars-cov-2 infection by rt-pcr * currently diagnosed with mild-to-moderate symptoms of covid-19 at home in self-isolation within 3 days of sars-cov-2 infection. * displaying typical symptoms of covid-19 such as a high temperature, a new, continuous cough, a loss or change to sense of smell or taste * patients who have signed informed consent. exclusion criteria: * patients with proven hypersensitivity or allergic reaction to quercetin * manifest contrary will

Keywords: covid-19, quercetin phytosome, anti-inflammatory, immunomodulatory, respiratory distress
primary prevention icd french registry

Conditions: Evaluation of Primary Prevention ICD in Real Life

Summary: the indication of implantable cardioverter defibrillator (icd) therapy for primary prevention of sudden cardiac death has been introduced later in france than in other parts of the world. overall, we aimed to assess the risk-benefit ratio of this strategy over a 10 year period.


Eligibility criteria:
inclusion criteria: * coronary artery disease or dilated cardiomyopathy with low ejection fraction implanted with an icd in the setting of primary prevention (criteria at the discretion of the physician) exclusion criteria: * setting of secondary prevention * other cardiopathies such as congenital, channelopathies, valvulopathies

Keywords: implantable cardioverter defibrillator death shock mortality complication sudden death